Regulatory Affairs Manager

ABOUT:

Are you passionate about advancing treatments for life-changing conditions? This global specialty pharmaceutical leader is transforming the landscape of genetic, metabolic, and systemic disorders. With a cutting-edge focus on melanocortin technology, they are on a mission to build a world-class melanocortin house-bringing hope to patients with life-threatening and acute conditions. With 10 products in the pipeline, ranging from pre-clinical to commercial, the company is looking to bring on a Regulatory Manager to their US site (California; However, this role can be remote).

Key Responsibilities:

1. Assist in the development of the ongoing global regulatory strategy.
2. Submissions of NDAs and amendments.
3. Applications and submissions to the FDA as required following post approval obligations and commitments, as well as prepare response to questions raised by FDA.
4. Maintain all approvals by submitting annual updates as needed (example Orphan designations, Investigator Brochure).
5. Support Quality and Pharmacovigilance colleagues in systems management.
6. Prepare and/or collate all documentation to support clinical trial applications.
7. Assist sites in submitting applications to IRBs, and preparing responses to questions raised by IRBs and updated documentation as required.
8. Ensure investigation medicinal product is supplied to the study sites in compliance with all regulatory requirements, including packaging.
9. Manage packaging material manufacturing and create secondary packaging material.
10. Review and approve contract manufacturer's specifications and packaging documents.

Qualifications:

1. Minimum 5 years pharmaceutical industry experience.
2. Proven experience in preparation of New Drug Applications.
3. Proven experience in regulatory management of centrally approved products.
4. Understanding of Orphan Drug requirements.
5. Proven understanding of eCTD Modules 1-5.
6. Preparation of marketing authorization applications in eCTD format.
7. Proven experience in labelling, pricing and reimbursement procedures (desirable).
8. Preparation of CTAs to support clinical trials (desirable).